FDA testing finds low contaminant levels in infant formula, supporting safety of US supply

The US Food and Drug Administration (FDA) has reported that contaminant levels in infant formula sold in the United States are low or undetectable in most products, based on a large-scale market basket survey conducted between 2023 and 2025. The findings are part of the agency’s broader effort to monitor and reduce exposure to environmental contaminants in foods consumed by infants and young children.

According to the FDA, the testing, conducted under Operation Stork Speed, represents “the largest and most comprehensive examination of chemical contaminants in infant formula available on the US market” and “affirm[s] that infant formula is safe.”

The survey included 312 samples across 16 brands, encompassing powdered, liquid concentrate, and ready-to-feed formulas. Products represented a range of protein sources, including cow’s milk, soy, and amino acid–based formulations. Samples were tested for multiple contaminants, including heavy metals such as arsenic, cadmium, lead, and mercury, as well as per- and polyfluoroalkyl substances (PFAS), pesticides, and phthalates.

What did FDA testing show?

Across the products tested, the FDA reported that “the majority of infant formula samples had undetectable or very low levels of contaminants.” Mercury, for example, was not detected in 95% of samples, while pesticides were absent in 99% of samples. Glyphosate and glufosinate were not detected in any samples.

For heavy metals, detected levels remained low. Lead concentrations ranged from not detected to 1.1 parts per billion (ppb), with 95% of samples containing less than 0.5 ppb. Arsenic levels ranged from not detected to 4.7 ppb, with most samples below 2.0 ppb. Cadmium concentrations were also low, with a median of 0.2 ppb.

PFAS compounds were largely absent, with 25 of 30 compounds not detected in any samples. Among those detected, concentrations were measured in parts per trillion (ppt), reflecting extremely low levels. The most commonly identified PFAS compound, perfluorooctanesulfonic acid (PFOS), was found in approximately half of the samples but at low concentrations.

Phthalates were not detected in more than half of the samples, and when present, levels varied widely but remained within low concentration ranges. The FDA noted that some findings triggered additional follow-up actions as part of ongoing monitoring and risk management efforts.

How should clinicians interpret these findings?

The FDA emphasized that the detection of contaminants does not necessarily indicate a safety concern. “Contaminants can be present in foods, even in small amounts, due to their natural occurrence in soil, water, and air,” the agency stated. Advances in testing methods allow for detection at extremely low levels that may not pose a clinical risk.

The agency also highlighted the role of its Closer to Zero initiative, which aims to reduce dietary exposure to contaminants as much as possible while maintaining access to nutritious foods. Infants and young children are prioritized due to increased vulnerability related to body size and developing organ systems.

Ongoing monitoring and future steps

The FDA noted that market basket surveys provide a snapshot of products available at a given time and may not capture variability across production lots. As a result, the agency plans to continue testing and collaborate with manufacturers to identify potential sources of contamination, including ingredient sourcing and production processes.

The agency also continues to develop and validate specialized analytical methods to detect contaminants at low concentrations. These methods require controlled laboratory conditions and are tailored specifically for food matrices such as infant formula.

Context for pediatric care

Although the FDA also conducted limited testing of donor human milk, the agency cautioned that those findings cannot be generalized broadly. Importantly, it reaffirmed that breast milk remains the optimal source of infant nutrition when available.

For pediatricians counseling families, the FDA’s findings provide reassurance regarding the safety of infant formula in the United States. The agency concluded that “parents and caregivers can continue to feel confident about the safety of infant formula,” while ongoing surveillance efforts aim to further reduce exposure to environmental contaminants.

Reference

FDA’s infant formula product testing results. FDA. Updated February 26, 2026. Accessed April 29, 2026. https://www.fda.gov/food/infant-formula-homepage/fdas-infant-formula-product-testing-results